Job Description
Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is a clinical-stage biotech organization based in the Bay Area seeking a Senior Statistical Programmer. This role will focus on CDISC SDTM standards, requiring expertise in SDTM mapping and implementation for oncology clinical trials, while providing support and technical guidance to cross-functional teams.
- Responsibilities
- Lead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies
- Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements
- Develop and maintain SDTM specifications and mapping documentation
- Perform hands-on SAS programming to create, validate, and quality control SDTM datasets
- Ensure SDTM deliverables are submission-ready and compliant with regulatory standards
- Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues
- Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping
- Support regulatory submissions and respond to data-related queries as needed
- Skills
- 10–15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companies
- Extensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trials
- Oncology experience required, with solid tumor experience strongly preferred (RECIST criteria)
- Advanced SAS programming skills with a focus on SDTM dataset creation and validation
- Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA)
- Ability to work independently and serve as an SDTM subject matter expert within the programming team
- Excellent communication skills and ability to collaborate effectively in a cross-functional environment
- Company Overview
- Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. It was founded in 2010, and is headquartered in Cupertino, California, USA, with a workforce of 51-200 employees. Its website is http://redbock.com/.
- Company H1B Sponsorship
- Redbock - an NES Fircroft company has a track record of offering H1B sponsorships, with 8 in 2025, 5 in 2024, 1 in 2023, 1 in 2022, 8 in 2021, 9 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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